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LY3962681

Phase 1

Parkinson's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

LY3962681 · 1 trial · 1 indication

Phase 1 1
NCT06565195A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's DiseaseParkinson's Disease
RECRUITING124 Analytics
PHASE1RECRUITING
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Serious Adverse Events (SAEs)
Up to 76 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 76 weeks
Number of discontinuations due to Adverse Events (AEs)
Up to 76 weeks

Secondary Endpoints

LY3962681 Maximum Observed Concentration (Cmax)
Up to 76 weeks
LY3962681 area under the concentration versus time curve (AUC)
Up to 76 weeks
Change from baseline in CSF total alpha-synuclein
Up to 76 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3962681 (SAD)EXPERIMENTALSingle ascending dose of LY3962681 administered intrathecally (IT) to healthy volunteers.
Placebo (SAD)PLACEBO_COMPARATORSingle ascending dose of placebo (aCSF) administered intrathecally (IT) to healthy volunteers.
LY3962681 (MAD)EXPERIMENTALMultiple ascending doses of LY3962681 administered IT to participants with Parkinson's disease.
Placebo (MAD)PLACEBO_COMPARATORMultiple ascending doses of placebo (aCSF) administered IT to participants with Parkinson's disease.

Interventions

NameTypeDescription
LY3962681DRUGIT injection
Placebo (aCSF)OTHERIT injection
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria: * Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study. * A Montreal Cognitive Assessment score greater than or equal to 24. MAD study only * Stable use of background medications at least 8 weeks prior to IP administration, i...

Countries:United StatesGermanyJapanNetherlandsUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMSep 1, 2026NCT06565195primaryCompletionDate: changed
MEDIUMSep 1, 2026NCT06565195primaryCompletionDate: changed

Frequently asked questions about LY3962681

What is LY3962681 used for in Parkinson's Disease?

LY3962681 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development, with a trial enrolling healthy volunteers and patients with Parkinson's Disease to evaluate its safety and tolerability.

What does LY3962681 target?

LY3962681 is a small molecule being studied for Parkinson's Disease. Its specific molecular target has not been disclosed in available clinical trial information. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and Parkinson's patients.

Who makes LY3962681?

LY3962681 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy volunteers and patients with Parkinson's Disease.

What phase is LY3962681 in?

LY3962681 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial is currently recruiting participants to study the drug's safety and how it is processed by the body in healthy volunteers and Parkinson's Disease patients.

What clinical trials is LY3962681 in?

LY3962681 is being studied in a Phase 1 clinical trial registered as NCT06565195. This randomized, double-blind, controlled trial is recruiting 124 participants across the United States, Germany, Japan, Netherlands, and United Kingdom. The study includes healthy volunteers aged 30 years and older and patients with Parkinson's Disease.